The Americas

Regulatory news in the Americas

Dominican Republic – Dominican Healthy Organization presented observations on the resolution on Front Labeling of Foods

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The coalition Dominicana Saludable presented details of the process and content of the draft resolution on Front-End Nutritional Warning Labeling (EFAN in Spanish) that is being managed by the Ministry of Public Health.
The entity informed that the EFAN resolution project has been in process for more than two years and that so far we do not have a final document, much less an official regulation.
It is worth noting that this is the closest we have been to the EFAN Resolution, since last Monday the 13th was the deadline for the public hearing to propose the changes that the public considered important.
We hope that the official document will be released as soon as possible, although we know that strong interests linked to the food industry are pressuring so that this resolution does not come out and if it does come out that it does not comply with the standards established by the Pan American Health Organization and other entities in the Region that have made their recommendations to the Ministry of Health.

Brazil – ANVISA publishes the 9th edition of the Q&A guide on dietary supplements

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The National Health Surveillance Agency (ANVISA in Portuguese) has published the update (9th edition) of the guide of questions and answers on dietary supplements.
The document contains updates resulting from the publication or revision of food regulations, with emphasis on RDC 843/2024 and IN 281/2024, dealing with food regularization, and RDC 839/2023, on the safety assessment of novel foods and ingredients. To provide greater clarity, some questions have been revised and grouped and grammatical adjustments have been made, ensuring a simpler and more accessible language for readers. The questions were also renumbered, with the aim of improving organization and facilitating consultation by topic.

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Peru – Health Ministry issues alert on red dye FD&C Red No. 3 banned in food in the U.S

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The Peruvian Ministry of Health (MINSA in Spanish) launched an alert to ask people to avoid the consumption of food and beverages containing the red dye n°3, which “due to its serious health implications (consequences)” has been banned by the U.S. Food and Drug Administration (FDA).

The Minsa confirmed in a statement that last January 15 the FDA “issued a historic ban on its use due to the health risks it represents, particularly its link to cancer”.

It explained that the synthetic dye red No. 3, also known as erythrosine or FD&C Red No. 3, has been commonly used in foods, beverages and medicines to provide a bright red color to products such as candies, cakes, cookies, frozen desserts, icings and some medicines.

Peru – Alcoholic beverage labeling proposed to display warning about cancer risks from alcoholic beverage consumption

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Congressman Idelso Garcia presented a bill that seeks to establish labeling on alcoholic beverages to warn consumers about the types of cancer they may suffer from their consumption. According to the National Institute of Mental Health, around 35% of Peruvians have addiction problems.
Through Bill No. 9973/2024-CR, legislator Idelso García proposes to safeguard consumers’ right to information through the use of informative labels on alcoholic beverages, so as to warn about the possible risks of contracting different types of cancer as a consequence of their ingestion.
To this end, it seeks to amend Article 7 of Law No. 28861, which regulates the Commercialization, Consumption and Advertising of Alcoholic Beverages (Law No. 28681). Through this change, it is provided that in a space of no less than 10% of the total area of the packaging, wrapping and related items, as well as on the labels of the product containers of any liquor, the phrase: “Drinking alcoholic beverages in excess increases the risk of developing various diseases including certain types of cancer”.

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Argentina – Presidency issues Decree simplifying food imports and exports

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As part of the measures being taken by the national government to speed up bureaucratic procedures, Decree No 35/2025, which amends Decree No 2126/1971, which regulates Law 18.284 on the Argentine Food Code, was published today, simplifying and streamlining the sanitary management of imports and exports of food and related products.
The National Administration of Medicines, Food and Medical Technology (ANMAT in Spanish) informs that, as from the publication of this new decree, food products, packaging and materials in contact with food under its competence, which have certification issued by countries considered as high sanitary surveillance or with which economic integration treaties or reciprocity agreements detailed in the decree are in force, may enter the country by presenting an Import Affidavit, as long as they have a marketing authorization or certificate of free sale of the product -or a similar document- approved by the competent health authority of the country of origin, regardless of whether or not the products are covered by national regulations.
ANMAT will soon publish the complementary provisions and procedures to carry out the implementation of this new regulation.

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